A new early detection test for prostate cancer provides patients with an individualized prostate cancer risk estimate that may help them avoid invasive and painful prostate biopsies.
The test, called MyProstateScore™, (MPS) detects the presence of two genes, TMPRSS2:ERG and PCA3, in the urine. The identification of these genes helps to accurately predict clinically significant prostate cancer.
Experts from LynxDx, the company that developed the test, explain its benefits.
Arul Chinnaiyan, M.D., Ph.D.
Spencer Heaton, M.D., M.B.A.
Chief Medical and Commercial Officer, LynxDx
How prevalent is prostate cancer in the U.S. today?
Steven Riggs: One in six men will develop prostate cancer. However, only 10% of those will actually face a life-threatening disease. Prostate cancer screening is routinely performed during an annual physical. When men receive an elevated PSA result, and they hear the words ‘possible cancer’, it’s very scary. Oftentimes, the next step in the diagnostic process is a biopsy.
Biopsies are often painful procedures that may not be necessary. Three out of four men who undergo a biopsy receive negative results. A PSA test is often influenced by factors other than cancer, like an enlarged prostate, vigorous exercise, recent ejaculation, and medications. Unnecessary biopsies cause the patient stress, discomfort and money.
What is special about MPS?
Arul Chinnaiyan: We want to help patients avoid unnecessary biopsies. We provide a diagnostic test that can rule out the need for a biopsy in some men with a high PSA. In addition, the results they receive from MPS can help guide them, their loved ones, and their physician, in making a clinical determination of the next steps. With the MPS test, patients will learn if they are at high risk of a clinically significant cancer or if their PSA test actually returned a false positive result.
How does the test work?
SR: The test is performed in a doctor’s office. It begins with a standard digital rectal exam followed by a urine sample. The physician’s office sends the sample to our lab where we check for very specific genetic markers that are commonly indicative of prostate cancer. Results are sent back to the patient’s doctor typically within a week.
How accurate are the results?
Spencer Heaton: When used in patients with an elevated PSA who have been referred for their first prostate biopsy, 98% of the time, a negative test result is accurate, which is a better clinical indicator than any other tests on the market.
Why avoid a biopsy?
SR: Most men aren’t familiar with how a prostate biopsy procedure is performed. The physician inserts a large gauge needle into the prostate, typically at least 12 times, to obtain the specimen. Biopsies carry the risk of infection, including urinary tract infections, that sometimes lead to sepsis. They also cause bruising, bleeding, urinary problems, as well as sexual dysfunction.
Is MyProstateScore unique?
SH: MPS is unique in that it is the only test on the market that measures the level of the novel gene fusion called TMPRSS2:ERG.
Dr. Chinnaiyan’s discovery of this gene fusion earned him international recognition from a prestigious organization.
How does MPS benefit the patient? The provider?
SR: One in three biopsies can be avoided through MPS. This test saves healthcare costs, helps the patients live healthier lives, and gives them the confidence that this course of action is directed by clinically-based evidence.
Is the test reimbursable by insurance? If not, how much does this cost the patient?
AC: Patients can receive MyProstateScore through their urologist or primary care physician. We are not billing insurance companies or Medicare until we receive final approval through the recently-announced decision that Medicare intends to cover prostate biomarker diagnostic tests. This decision illustrates the value of tests like MyProstateScore to men’s overall health. We expect that these diagnostic tests will be covered in the near future.
How do physicians request/obtain MPS for patients?
SR: They can easily request information on how to order MPS by visiting MyProstateScore.com.